MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK ORTHOPEDIC SALVAGE SYSTEM STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).B3: event date is the publication date of the article.G2: wier j, liu kc, piple as, christ ab, longjohn db, oakes da, heckmann nd.Factors associated with failure following proximal femoral replacement for salvage hip surgery for nononcologic indications.J arthroplasty.2023 may 19:s0883-5403(23)00545-4.Doi: 10.1016/j.Arth.2023.05.021.Epub ahead of print.Pmid: 37209911.Mechanical (g04) / stem.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01640, 0001825034-2023-01641, 0001825034-2023-01642, 0001825034-2023-01643, 0001825034-2023-01644.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported through a journal article that one patient experienced postoperative sciatic nerve palsy on an unknown date.No further intervention has been reported to date.Attempts have been made and no further information is available.

• Brand Name: UNK ORTHOPEDIC SALVAGE SYSTEM STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17352302
• MDR Text Key: 319378636
• Report Number: 0001825034-2023-01639
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK OSS STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other